PregnancymatventNCT02339389
Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?
An observational study of Pregnancy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Epidural techniques offer the advantage of being able to titrate the level, density, and duration of the blockade through the use of a catheter and are associated with relative maternal hemodynamic stability. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Labor analgesia
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2014to 2 Sep 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Informed consent will be obtained by one of the licensed physician investigators at the earliest opportunity when the subject arrives on the labor suite and following contact with their provider. While the timing between subject arrival and request for neuraxial analgesia can be variable, in subjects who present in early labor at less than 5 cm cervial dilation, there is often several hours available for a subject to consider 1) whether they desire a central neuraxial technique during labor, and 2) whether they would be willing to participate in this study.
Who may be able to join
- Parturient with no major co-morbidities
- Singleton, vertex gestation at term (38-42 weeks)
- Less than 5 cm dilation
- Intact fetal membranes or rupture for < 6 hrs.
- Desire to have an epidural technique for labor analgesia
Who cannot join
- Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
- Any contraindication to the administration of an epidural technique
- History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications
- Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. vaginal birth after cesarean section, history of uterine rupture)
- Evidence of anticipated fetal anomalies
- Signs or symptoms consistent with an infection or sepsis; baseline temperature < 37 degrees Celsius, or 99 degrees Fahrenheit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02090
About this study
Epidural techniques offer the advantage of being able to titrate the level, density, and duration of the blockade through the use of a catheter and are associated with relative maternal hemodynamic stability. One of the disadvantages, however, include a raise in maternal temperature that is attributed to labor epidural technique. This study will assess if decreased maternal ventilation following induction of labor analgesia causes a raise in temperature.
Read the detailed description
Fever in labor complicates up to one-third of deliveries. The etiologies of intrapartum fever are diverse and include maternal chorioamnionitis, and other infections. In addition, epidural analgesia used for pain relief in labor is associated with mild maternal temperature increase and overt fever. Originally dismissed by obstetric anesthesiologists as a clinical curiosity of little consequence, epidural-associated hyperthermia may lead to significant maternal as well as fetal or neonatal adverse effects. Observational investigations performed 2 decades ago demonstrated a gradual increase in temperature in laboring parturients with epidural analgesia not see in those electing systemic opioid analgesia or no analgesia. The epidural group showed an average increase in temperature of approximately 1 degree centigrade over 7 hours whereas temperatures in non-epidural group remained constant. No evidence of clinical infection was reported in any of the women. Many studies confirmed these raises in temperature in epidural group compared to no epidural group during labor and delivery.
Several mechanisms have been postulated with no study reaching a conclusion. The mechanisms suggested include imbalance between heat production and heat dissipation, effect of opioid on interleukin-2, markers of inflammation induced by epidural analgesia, etc. Our study aims at the first mechanism. It may be a physiological process that leads to an imbalance between heat production and heat dissipation. Labor is a hyper metabolic state and increased heat production is dissipated via increased ventilation that is associated with labor pains with no epidural pain relief. It is conceivable that laboring women with pain relief subsequent to epidural analgesia, a decrease in ventilations may occur leading to decreased heat dissipation.
- Conditions
- Pregnancy
- Being tested
- Labor analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labor analgesiaOther
Measuring maternal ventilation after placement of epidural analgesia compared to baseline
| Study group | Role | What they receive |
|---|---|---|
| ventilation during labor analgesia | We are simply measuring ventilation changes that occur following labor analgesia. Receives: Other: Labor analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Maternal Ventilation During Labor Analgesia
If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval
Measured: Ventilation parameters measured at 2 hour and 4 hour
Secondary outcomes (1)
If Maternal Temperature Increases During Labor Analgesia
If maternal temperature increases during labor analgesia
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study start14 Aug 2014
- Primary completion2 Sep 2016
- Study completion2 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhavani Shankar Kodali, Brigham and Women's Hospital
- Investigators
- Bhavani Kodali, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339389
- Sponsor's protocol ID
- 2014P00152
- Acronym
- matvent
- Status last verified
- Aug 2017
- First submitted
- 6 Jan 2015
- Last updated
- 19 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kodali BS, Choi L, Chau A, Harvey BC, Brayanov J, Tsen LC, Palanisamy A. Use of a novel non-invasive respiratory monitor to study changes in pulmonary ventilation during labor epidural analgesia. J Clin Monit Comput. 2020 Jun;34(3):567-574. doi: 10.1007/s10877-019-00349-1. Epub 2019 Jul 8.
PubMed 31286333
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Maternal Fever During Labor Analgesia Has Any Relationship With Maternal Ventilation?
- ClinicalTrials.gov ID
- NCT02339389
- Acronym / sponsor ID
- matvent / 2014P00152
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Aug 2014 (actual)
- Primary completion
- 2 Sep 2016 (actual)
- Study completion
- 2 Sep 2016 (actual)
- First posted
- 15 Jan 2015 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidural techniques offer the advantage of being able to titrate the level, density, and duration of the blockade through the use of a catheter and are associated with relative maternal hemodynamic stability. One of the disadvantages, however, include a raise in maternal temperature that is attributed to labor epidural technique. This study will assess if decreased maternal ventilation following induction of labor analgesia causes a raise in temperature.
Detailed description
Fever in labor complicates up to one-third of deliveries. The etiologies of intrapartum fever are diverse and include maternal chorioamnionitis, and other infections. In addition, epidural analgesia used for pain relief in labor is associated with mild maternal temperature increase and overt fever. Originally dismissed by obstetric anesthesiologists as a clinical curiosity of little consequence, epidural-associated hyperthermia may lead to significant maternal as well as fetal or neonatal adverse effects. Observational investigations performed 2 decades ago demonstrated a gradual increase in temperature in laboring parturients with epidural analgesia not see in those electing systemic opioid analgesia or no analgesia. The epidural group showed an average increase in temperature of approximately 1 degree centigrade over 7 hours whereas temperatures in non-epidural group remained constant. No evidence of clinical infection was reported in any of the women. Many studies confirmed these raises in temperature in epidural group compared to no epidural group during labor and delivery.
Several mechanisms have been postulated with no study reaching a conclusion. The mechanisms suggested include imbalance between heat production and heat dissipation, effect of opioid on interleukin-2, markers of inflammation induced by epidural analgesia, etc. Our study aims at the first mechanism. It may be a physiological process that leads to an imbalance between heat production and heat dissipation. Labor is a hyper metabolic state and increased heat production is dissipated via increased ventilation that is associated with labor pains with no epidural pain relief. It is conceivable that laboring women with pain relief subsequent to epidural analgesia, a decrease in ventilations may occur leading to decreased heat dissipation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilation during labor analgesia | – | Other: Labor analgesiaWe are simply measuring ventilation changes that occur following labor analgesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Informed consent will be obtained by one of the licensed physician investigators at the earliest opportunity when the subject arrives on the labor suite and following contact with their provider. While the timing between subject arrival and request for neuraxial analgesia can be variable, in subjects who present in early labor at less than 5 cm cervial dilation, there is often several hours available for a subject to consider 1) whether they desire a central neuraxial technique during labor, and 2) whether they would be willing to participate in this study.
Key inclusion criteria (5 listed)
- Parturient with no major co-morbidities
- Singleton, vertex gestation at term (38-42 weeks)
- Less than 5 cm dilation
- Intact fetal membranes or rupture for < 6 hrs.
- Desire to have an epidural technique for labor analgesia
Key exclusion criteria (6 listed)
- Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
- Any contraindication to the administration of an epidural technique
- History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications
- Current or historical evidence of a disease which may result in the risk of a cesarean delivery (i.e. vaginal birth after cesarean section, history of uterine rupture)
- Evidence of anticipated fetal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Labor analgesiaMeasuring maternal ventilation after placement of epidural analgesia compared to baseline | Other | ventilation during labor analgesia |
Primary outcome
Changes in Maternal Ventilation During Labor Analgesia
Time frame: Ventilation parameters measured at 2 hour and 4 hour
If Maternal Ventilation decreases following labor analgesia at 2 hour and 4 interval
1 secondary outcome
If Maternal Temperature Increases During Labor Analgesia
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31286333Kodali BS, Choi L, Chau A, Harvey BC, Brayanov J, Tsen LC, Palanisamy A. Use of a novel non-invasive respiratory monitor to study changes in pulmonary ventilation during labor epidural analgesia. J Clin Monit Comput. 2020 Jun;34(3):567-574. doi: 10.1007/s10877-019-00349-1. Epub 2019 Jul 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhavani Kodali, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Maternal Ventilation During Labor Analgesia (time frame: Ventilation parameters measured at 2 hour and 4 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.